FDA applicant

Kitazato Medical Co., Ltd.

Austin, TX3 decisions2012–20130 recalls

FDA records 3 decisions for Kitazato Medical Co., Ltd. (Austin, TX) from 2012 to 2013: 3 510(k) clearances. Most are in product codes MQF (Catheter, Assisted Reproduction) and MQE (Needle, Assisted Reproduction). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Kitazato Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2012high 2 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Kitazato Medical Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kitazato Medical Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Kitazato”

FDA records each applicant name separately; these may or may not be the same firm.

Kitazato Corporation 13 Kitazato Biopharma Co., Ltd. 6

Kitazato Medical Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Kitazato”